New Risk • May 15
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 1.6% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. Currently, the following risks have been identified for the company: Major Risks Earnings are forecast to decline by an average of 1.6% per year for the foreseeable future. Shareholders have been substantially diluted in the past year (72% increase in shares outstanding). Revenue is less than US$1m. Minor Risk Currently unprofitable and not forecast to become profitable over next 3 years (US$85m net loss in 3 years). Announcement • May 08
Eupraxia Pharmaceuticals Inc Announces First Release of EoEHSS Sub Scores Data from Ongoing Phase 1B/2A Resolve Trial in Eosinophilic Esophagitis Eupraxia Pharmaceuticals Inc. announced the first release of sub score data from the Eosinophilic Esophagitis Histologic Scoring System (“EoEHSS”) in its ongoing Phase 1b/2a part of the RESOLVE trial evaluating EP-104GI for the treatment of eosinophilic esophagitis (“EoE”). EoEHSS is a standardized method used to monitor esophageal tissue damage in EoE patients. Sub scores of EoEHSS are reported to specifically evaluate the tissue inflammation and tissue architecture (which is a measure of fibrosis). EoEHSS sub scores for inflammation demonstrated improvements in all reported cohorts at both 12 weeks (n=31) and 36 weeks (n=27). EoEHSS sub scores for tissue architecture (fibrosis) demonstrated improvements across most reported cohorts at 12 and 36 weeks. The largest response in both the inflammatory and the architectural (fibrosis) sub scores was seen at the highest dose tested. EoEHSS is comprised of eight individual features: four evaluating inflammation (EoEHSS-i) and four evaluating architectural and fibrotic aspects (EoEHSS-a) of the disease. Each sub score measures both grade (severity of the disease feature) and stage (extent of the disease feature). In the Phase 1b/2a portion of the RESOLVE trial, EoEHSS data were measured on all cohorts at baseline, week-4, week-12, and for patients in Cohorts 5-9 at week 36. Data on EoEHSS sub scores were presented at DDW for cohorts followed up to 52 weeks (cohorts 5-9). Data were presented on EoEHSS-i and EoEHSS-a for these cohorts at week 12 and at week 36 (with the exception of week 36 data from cohort 8b which has not yet been measured). For EoEHSS-i (measuring inflammation) improvements in both grade and stage were seen across all cohorts presented at week 12 and week 36. For EoEHSS-a (measuring architectural and fibrotic aspects of the disease) improvements in both grade and stage were seen across most cohorts presented at week 12 and week 36. The largest improvements in both sub scores at week 12 and week 36 were observed for the highest dose (cohort 9). In this cohort: The improvement in EoEHSS-i grade and stage was greater than 90% at both 12 and 36 weeks. The improvement in EoEHSS-a grade and stage was greater than 83% at both 12 and 36 weeks. The Phase 1b/2a part of the RESOLVE trial is a multicenter, open-label, dose-escalation study evaluating the safety, tolerability, pharmacokinetics, and efficacy of EP-104GI in adults with histologically confirmed active EoE. The treatment is administered as a single dose via 4 to 20 esophageal wall injections, with dose escalations modifying either the dose per site and/or the number of sites. Participants were followed for up to 24 weeks in Cohorts 1-4 (4x1mg, 8x1mg, 8x2.5mg and 12x2.5mg) or 52 weeks in Cohorts 5-9 (12x4mg, 16x4mg, 20x4mg, 20x6mg and 20x8mg). Eupraxia plans to disclose additional data from the open-label Phase 1b/2a part of the RESOLVE trial in the coming months. The Phase 2b part of the RESOLVE trial, a randomized placebo-controlled study of EP-104GI, is currently recruiting both the 120mg (20x6mg) and 160mg (20x8mg) doses. The top-line data from the Phase 2b part of the RESOLVE trial is expected in Fourth Quarter 2026. Eupraxia's EP-104GI is currently in a Phase 1b/2 trial, the RESOLVE trial, for the treatment of EoE. EP-104GI is administered as an injection into the esophageal wall, providing local delivery of drug. Eupraxia also completed a Phase 2b clinical trial (SPRINGBOARD) of EP-104IAR for the treatment of pain due to knee osteoarthritis. The trial met its primary endpoint and three of the four secondary endpoints. In addition, Eupraxia is developing a pipeline of later and earlier-stage long-acting formulations. Potential pipeline indications include candidates for other inflammatory joint indications and oncology, each designed to improve on the activity and tolerability of currently approved drugs.